United States Government Printing Office printer prt distributor dst United States National Archives and Records Administration Federal Register Office author aut Government Organization text government publication eng FR Regulatory Information 2010_register executive 2010-09-03 article Rules and Regulations D09002ee18070b601 D09002ee18070b613 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplement provides for two new sizes of praziquantel and pyrantel pamoate tablets used in cats and kittens for the removal of various internal parasites and for a revised kitten age and weight restriction. 75 FR 54018 http://www.gpo.gov/fdsys/granule/FR-2010-09-03/2010-22043 2010-22043 FR03SE10-4 4160-01-S Docket No. FDA-2010-N-0002 http://www.gpo.gov/fdsys/granule/FR-2010-09-03/2010-22043/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-2010-09-03/html/2010-22043.htm http://www.gpo.gov/fdsys/pkg/FR-2010-09-03/pdf/2010-22043.pdf 1 p. 54018 54018 75 FR 54018 Title 21 Part 520 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel; Federal Register Vol. 75, Issue RULE 2010-22043 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2010-09-03 Docket No. FDA-2010-N-0002 4160-01-S 2010-22043 Final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplement provides for two new sizes of praziquantel and pyrantel pamoate tablets used in cats and kittens for the removal of various internal parasites and for a revised kitten age and weight restriction.

This rule is effective September 3, 2010. Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, email: melanie.berson@fda.hhs.gov. Oral Dosage Form New Animal Drugs: Praziquantel and Pyrantel , melanie.berson@fda.hhs.gov Vol. 75, no. 171 Office of the Federal Register, National Archives and Records Administration 2010-09-03 continuing daily deposited born digital 274 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 http://www.gpo.gov/fdsys/pkg/FR-2010-09-03 P0b002ee18070948a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR03SE10 http://www.gpo.gov/fdsys/pkg/FR-2010-09-03/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-2010-09-03/pdf/FR-2010-09-03.pdf http://www.gpo.gov/fdsys/pkg/FR-2010-09-03/xml/FR-2010-09-03.xml fdlp 54005 54270 DGPO 2010-09-03 2010-09-03 FR-2010-09-03 machine generated eng FR FR-2010-09-03 75 171